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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fat Reducing Low Level Laser
510(k) Number K243854
Device Name Contour Light (CL-100)
Applicant
Contour Research, LLC
200 Virginia St.
#8
Reno,  NV  89501
Applicant Contact Douglas Dreier
Correspondent
Bentley Biomedical Consulting, LLC
28241 Crown Valley Pkwy., Suite 510(K)
Laguna Nuguel,  CA  92677
Correspondent Contact Shepard Bentley
Regulation Number878.5400
Classification Product Code
OLI  
Date Received12/16/2024
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Clinical Trials NCT04451824
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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